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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-02-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
adopted May 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: DIN 66165 part 1 and 2: Sieving analysis
Version / remarks:
2016-08
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance, European Chemicals Agency
Version / remarks:
version 4.1, October 2015
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
The test item was tested as received. No further preliminary treatment such as drying or milling was performed.
Remarks on result:
not determinable
Remarks:
Due to the large size of the particles (99.54% by mass >500 µm by sieving), sieving was the method chosen. No MMAD can be determined from sieving - however, based on the large particle size there will be no relevant inhalable fraction.
Key result
Percentile:
D10
Mean:
1 100 µm
Remarks on result:
other: Range of particle size for mesh size 1000 µm: 1000 µm to 1250 µm
Percentile:
D50
Mean:
1 300 µm
Remarks on result:
other: Range of particle size for mesh size 1250 µm: 1250 µm to 1400 µm
Percentile:
D90
Mean:
1 500 µm
Remarks on result:
other: Range of particle size for mesh size 1400 µm: 1400 µm to 1600 µm

The test item consisted of granules (approximately 1 to 2 mm in diameter). Due to the size of the granules the particle size distribution was determined by dry sieving.

242.08 g of the test item were placed on the top sieve. After closing the sieve stack and placing it into the sieving machine sieving was performed for 5 min with amplitude of 1.5 mm. The particle size is shown in the following table:

Mesh size

Range of particle size

Fraction

Total

Fraction

Total

µm

µm

g

g

%

%

2000

> 2000

0.00

0.00

0.00

0.00

1700

1700 – 2000

0.05

0.05

0.02

0.02

1600

1600 – 1700

1.90

1.95

0.78

0.81

1400

1400 – 1600

54.43

56.38

22.48

23.29

1250

1250 – 1400

125.87

182.25

52.00

75.29

1000

1000 – 1250

56.79

239.04

23.46

98.74

800

800 – 1000

1.62

240.66

0.67

99.41

500

500 – 800

0.31

240.97

0.13

99.54

300

300 – 500

0.11

241.08

0.05

99.59

250

250 - 300

0.08

241.16

0.03

99.62

Receiver pan

0 – 250

0.92

242.08

0.38

100.00

The percentiles of the particle size distribution were estimated from cumulative plotting of the size fraction (by mass) given in the table above against the mesh size (µm) on the abscissa.

The particle size D50estimated from this measurement was:

D50= 1300 µm

The particle size D10estimated from this measurement was:

D10= 1100 µm

The particle size D90estimated from this measurement was:

D90= 1500 µm

Conclusions:
Due to the large size of the particles (99.54% by mass >500 µm by sieving), sieving was the method chosen. No MMAD can be determined from sieving - however, based on the large particle size there will be no relevant inhalable fraction:
D50 = 1300 µm
D10 = 1100 µm
D90 = 1500 µm
Executive summary:

The particle size distribution was determined for the submission substance according to OECD 110 and DIN 66165 part 1 and 2: Sieving analysis, under consideration of ECHA guidance document R.7a. The test item consisted of granules (approximately 1 to 2 mm in diameter). Due to the size of the granules the particle size distribution was determined by dry sieving. No MMAD can be determined from sieving - however, based on the large particle size there will be no relevant inhalable fraction.

The percentiles of the particle size distribution were estimated from cumulative plotting of the size fraction (by mass) against the mesh size (µm) on the abscissa.

The particle size D50estimated from this measurement was:

D50= 1300 µm

The particle size D10estimated from this measurement was:

D10= 1100 µm

The particle size D90estimated from this measurement was:

D90= 1500 µm

Description of key information

Due to the large size of the particles (99.54% by mass >500 µm by sieving), sieving was the method chosen (OECD 110, DIN66165 part 1 and 2: sieving analysis; RL1, 2017). No MMAD can be determined from sieving - however, based on the large particle size there will be no relevant inhalable fraction:

D50 = 1300 µm

D10 = 1100 µm

D90 = 1500 µm

Additional information

The particle size distribution was determined for the submission substance according to OECD 110 and DIN 66165 part 1 and 2: Sieving analysis, under consideration of ECHA guidance document R.7a. The test item consisted of granules (approximately 1 to 2 mm in diameter). Due to the size of the granules the particle size distribution was determined by dry sieving. No MMAD can be determined from sieving - however, based on the large particle size there will be no relevant inhalable fraction.

The percentiles of the particle size distribution were estimated from cumulative plotting of the size fraction (by mass) against the mesh size (µm) on the abscissa.

The particle size D50estimated from this measurement was:

D50= 1300 µm

The particle size D10estimated from this measurement was:

D10= 1100 µm

The particle size D90estimated from this measurement was:

D90= 1500 µm